Did the FDA approve over-the-counter birth control?

Yes, FDA approved one over-the–counter progesterone only birth control pill on June 13th, 2023. The pill is a progesterone only pill and is expected to be available early 2024 as per Perrigo Company. Price is still unknown.

Do over-the-counter drugs require FDA approval?

Yes, over-the-counter (OTC) drugs do require FDA approval. The FDA regulates the sale and distribution of over-the-counter drugs to ensure their safety and effectiveness. Before a drug can be sold over-the-counter, it must undergo a rigorous review process by the FDA to assess its safety, efficacy, and appropriate use. The FDA evaluates the active ingredients, dosages, labeling, and potential side effects of the drug to determine if it meets the requirements for OTC status. Once approved, the drug can be sold directly to consumers without a prescription.

What is the FDA definition of over-the-counter medicine?

The FDA defines over-the-counter (OTC) medicines as drugs that are safe and effective for use without a prescription. These medications are typically used to treat common health conditions and can be purchased directly by consumers without the need for a healthcare provider's authorization. The FDA establishes specific criteria for a drug to be classified as OTC, including its safety profile, appropriate dosage, and clear labeling instructions for consumer use. OTC medicines are regulated by the FDA to ensure their quality, safety, and effectiveness.

What’s the difference between the Opill and regular birth control pills?

“Regular birth control pills”, aka combined oral birth control pills , contain estrogen and progesterone and require you to see a provider to get a prescription (doctor, pharmacist, physician’s assistant, nurse practitioner). Opill is a progesterone only pill, meaning it does not have estrogen. With the progesterone only over the counter pill, if you are late taking it by 3 hours, you will NOT be protected against pregnancy. If you had sex and took the Opill 3 hrs late, consider taking some emergency contraception to prevent unplanned pregnancy.

The Birth Control Pill That's Approved To Be Sell OTC

In a huge step towards improving women’s reproductive health, the U.S. Food and Drug Administration (FDA) has approved the availability of one over-the-counter (OTC) birth control pill. This decision marks a major milestone, providing women with increased accessibility, convenience, and control over one of their contraceptive choices, which is what we’re all about here at Pandia Health! Let’s learn more about what this pill (Opill) and what its approval means for women across the US.

What is the first OTC birth control pill called?

The new FDA approved over the counter birth control pill is called Opill and is a progesterone only pill, also known as “mini pill”. Here are some pros and cons summarized for you!

Positives of the new Over the counter birth control pill

You’ll be able to get it starting in 2024 without a prescription. This is great for anyone who doesn’t have access to a doctor/prescriber. (However, know that you can use Pandia Health’s expert birth control doctors in 17 states for only $30 once a year and there are other telemedicine companies out there too.)
It’s a progesterone only pill so if you have health conditions that contraindicate or make it so you can’t take estrogen, you can use this pill. This pill will be good for those who: are breastfeeding (estrogen might decrease breastmilk production if you take it before the baby is 6 months old), are smokers AND over 35 years of age, have lupus and antiphospholipid antibodies, have migraine with aura.

Negatives of the new Over the Counter birth control pill:

This type of pill needs to be taken at the same time every day to be effective, while with combined oral contraceptive pills you have a much longer window to take your pill. If you are late by 3 hrs taking the Opill, you will need to consider taking some Emergency Contraception if you had sex within the past 5 days and need to prevent pregnancy. So, get some emergency contraception ahead of time to have around in case of emergencies!
Also, for progesterone only pills only 10% of people can skip their monthly bleed on it; it is not guaranteed. At Pandia Health, our expert birth control doctors usually recommend combined birth control pills or birth control vaginal rings for skipping your monthly bleed (did you know you can make #PeriodsOptional).
Progesterone only pills do not consistently block ovulation and thus would not be ideal for those who have PolyCystic Ovarian Syndrome or who want to use birth control pills to decrease their risk of ovarian cancer.

How much does Opill cost?

Well, the price is still unknown. We hope it will be affordable for everyone because the Affordable Care Act does not cover over the counter birth control, meaning most insurance won’t cover it and people will need to pay out of pocket for it.

What implications does this new law have for society?

Increased Accessibility

By making one birth control pill available over the counter, the FDA has removed the barrier of requiring a prescription, making it easier for women to access this contraception. This change eliminates the need for doctor’s appointments and allows women to obtain this specific type of birth control pill directly from pharmacies, saving time and reducing healthcare costs. This is one of the reasons why most young women, teenagers and those dealing with financial struggles don’t access birth control.

Expanded Options

The FDA’s approval of OTC birth control pills expands the range of available contraceptive options without prescription required for those with uteri. It provides us with more choices and the ability to select a method that best suits our individual needs and preferences.

The Need for Education and Support

With the availability of OTC birth control pills, it is crucial to emphasize the importance of education and support. While this step forward in reproductive autonomy should be celebrated, women can only make informed decisions about their health if they are well informed. Women should be encouraged to consult with their doctors to ensure they understand the different types of birth control pills (“regular pills with estrogen and progesterone” vs progesterone only pills), their potential side effects, and proper usage before making a purchase. Additionally, pharmacies and healthcare providers should play a vital role in providing guidance and answering any questions women may have about OTC progesterone only pills.

It is crucial to ensure that pharmacists and pharmacy attendants are trained to provide careful instructions to the buyers of OTC progesterone only birth control pills. They should be knowledgeable about the different types of birth control pills available (over the counter and prescription), their proper usage, potential side effects, and any other relevant information. This training will enable them to offer accurate guidance to those with uteri seeking contraception and address any concerns or questions they may have. By emphasizing the importance of this training, pharmacies can play a significant role in promoting the safe and effective use of OTC progesterone only birth control pills, avoiding unwanted pregnancies or bad side effects.

Takeaway

The FDA’s approval of over-the-counter birth control pills is a significant advancement in women’s reproductive health. Since Roe V. Wade was overturned and some states started banning abortion, birth control access has become a more important, high priority issue. This new approval helps ease the situation by increasing accessibility (although the price of the medication is not known yet and it is only 1 of 30+ birth control pills) and availability. However, it is important to remember that this one OTC progesterone only birth control pill may not be the best option for everyone, and consulting with birth control knowledgeable doctors and pharmacists remains crucial to ensure the best contraceptive method is chosen.

At Pandia Health, we understand that each woman has unique needs and medical history that needs to be assessed to reduce the probability of side effects and find the birth control pill that works best for them. Our telemedicine service provides personalized care and attention from licensed expert doctors who are dedicated to helping you find the right hormonal treatment for your individual needs.

Our women’s birth control online telemedicine service provides the highest quality care for women’s reproductive health needs. We want to congratulate our peers on this great step towards women’s empowerment, but we also encourage you to be informed and to always discuss with a doctor before starting any medication. With over 30 types of birth control pills, patches, and rings available, we know that finding the right option can be overwhelming. That’s why we’re here to help you every step of the way if you need it.

FDA Approves Over-the-Counter Birth Control Pill: Improving Women’s Reproductive Health